Risk analysis and risk management

The HIPAA risk analysis and risk management requirement means you must document how you identify and prioritize risks to the confidentiality, integrity, and availability of ePHI, then track decisions and remediation to reduce those risks. Operationalize it by scoping all ePHI locations, assessing credible threats and vulnerabilities, assigning risk ratings, and maintaining a living remediation plan with owners and dates.

Key takeaways:

• Maintain a written, repeatable risk analysis method that covers every system, process, and third party path that touches ePHI ¹.
• Treat risk management as execution: documented risk decisions, remediation tracking, and evidence that fixes happened ¹.
• Your fastest audit win is an inventory-to-risk register-to-remediation chain that an auditor can follow end-to-end ¹.

CCOs and GRC leads often inherit “a risk assessment” that is really a one-time worksheet, a penetration test, or an IT ticket queue. HIPAA expects more discipline: a documented risk analysis focused on ePHI and ongoing risk management that shows what you decided to fix, when, and why. The practical test is simple: can you show a regulator or customer how ePHI is protected across your environment, including cloud services and third parties, and prove that known gaps are being reduced over time?

This page translates the HIPAA risk analysis and risk management requirement into an operator-ready playbook. You’ll get an implementation sequence, artifacts to retain, and the exam questions that typically expose weak programs. The emphasis is evidence. If you cannot produce the inventory, methodology, findings, and remediation trail on demand, your program will read as incomplete even if your technical controls are strong. The goal is to build a repeatable system that stays current through change, not a once-a-year document you dread updating.

Requirement: risk analysis and risk management requirement (HIPAA)

The HIPAA risk analysis and risk management requirement is to conduct and maintain a documented risk analysis for ePHI confidentiality, integrity, and availability, and then manage the risks you identify ¹. In practice, this is the backbone of a HIPAA Security Rule program because it connects your environment, your threats, your controls, and your remediation decisions into one auditable narrative.

Regulatory text

Regulatory excerpt (provided): “Conduct and maintain a documented risk analysis for ePHI confidentiality, integrity, and availability.” ¹

What an operator must do:

1. Conduct: Perform an assessment that identifies reasonably anticipated threats and vulnerabilities to ePHI and evaluates the likelihood and impact of those risks in your environment.
2. Maintain documented: Keep the methodology, inputs, results, and decisions in writing, and keep them current as systems, third parties, and workflows change.
3. Cover CIA for ePHI: Explicitly address confidentiality (unauthorized disclosure), integrity (unauthorized alteration/destruction), and availability (loss of access) for ePHI across its lifecycle ¹.

Plain-English interpretation

You need a defensible, written answer to: “Where is our ePHI, what could go wrong, how bad would it be, and what are we doing about it?” A “risk analysis” that ignores cloud apps, remote access, third parties, or backups usually fails in an audit because it does not reflect reality. A “risk management program” without remediation tracking also fails because you can’t prove risk reduction.

Who it applies to (entity and operational context)

Applies to:

• Covered Entities that create, receive, maintain, or transmit ePHI ¹.
• Business Associates that create, receive, maintain, or transmit ePHI on behalf of a Covered Entity ¹.

Operational contexts where this becomes urgent:

• Cloud migrations, EHR/EMR changes, identity provider changes, network redesigns.
• New patient engagement platforms, call center workflows, or analytics tooling.
• M&A, new facilities, new lines of business, and major third party onboarding where ePHI data flows expand.

What you actually need to do (step-by-step)

Step 1: Define scope and boundaries (make it auditable)

Create a written scope statement that answers:

• Which legal entity(ies) are included.
• Which environments are included (prod, non-prod, corporate IT, endpoints).
• Which ePHI forms are included (databases, file shares, images, logs, support tickets, backups).
• Which third parties handle ePHI and what role they play.

Operator tip: If you can’t point to an inventory, your scope will drift. Start with “systems that store/process/transmit ePHI” and expand to “systems that can access ePHI.”

Step 2: Build an ePHI asset + data flow inventory

Minimum inventory fields that auditors and assessors expect to see:

• Asset/system name, owner, environment, and criticality.
• ePHI type(s) handled and where stored.
• Ingress/egress points (APIs, SFTP, HL7 interfaces, portals).
• Authentication method, encryption status (at rest/in transit), logging coverage.
• Third parties involved and contract references.

Deliverable: ePHI System Inventory plus Data Flow Diagram(s) for key workflows (patient intake, clinical documentation, billing, support, reporting).

Step 3: Choose a risk methodology you can repeat

Document, in plain language:

• How you define threats, vulnerabilities, likelihood, and impact.
• Your scoring model (qualitative is fine if consistent).
• How you account for existing controls.
• What triggers an out-of-cycle update (major changes, incidents, new third parties).

Map your method to a recognizable structure (for internal alignment), such as NIST-style thinking (identify threats/vulnerabilities, likelihood/impact, residual risk). Keep the work product HIPAA-focused: ePHI CIA.

Step 4: Identify threats and vulnerabilities tied to your environment

Use a structured workshop approach with IT, Security, Compliance, Privacy, and key business owners. For each ePHI system and data flow, evaluate scenarios such as:

• Unauthorized access (weak MFA, shared accounts, excessive privileges).
• Data exfiltration (misconfigured cloud storage, insecure APIs).
• Integrity failures (inadequate change control, lack of input validation).
• Availability events (ransomware, single points of failure, backup gaps).
• Third party failures (service outages, subcontractor access, offboarding gaps).

Deliverable: Risk Register entries tied to specific assets/data flows, not generic statements.

Step 5: Assign risk ratings and define “risk acceptance” rules

For each risk, record:

• Likelihood rating rationale.
• Impact rating rationale (explicitly tied to ePHI CIA and operations).
• Inherent risk, existing controls, and residual risk.
• Proposed treatment: remediate, mitigate, transfer, or accept.

Define who can accept risk and at what level (e.g., system owner recommends, Security/Compliance reviews, executive signs for high risks). The point is consistent governance, not bureaucracy.

Step 6: Create and run a remediation plan (risk management)

Convert high-priority risks into a trackable remediation backlog:

• Control change needed (technical, administrative, physical).
• Owner, dependencies, target date, and validation method.
• Status updates and evidence links (tickets, configs, screenshots, policies).

This is where many programs break: teams identify risks, then stop. Your remediation tracker is the proof of “risk management” work over time ¹.

Step 7: Validate fixes and close the loop

Define closure criteria per remediation item:

• What test proves the control works (access review results, backup restore test record, encryption setting verified, alert test).
• Who signs off and when.
• Residual risk after fix.

Step 8: Operationalize as a living program

Build “update triggers” into existing governance:

• Change management: new systems, major releases, network changes.
• Third party onboarding/offboarding: update inventories and risks.
• Incident response: feed root cause into the risk register.

Where Daydream fits naturally: teams often struggle with keeping inventories, risk decisions, and remediation evidence connected. Daydream can act as the system of record for risk analysis outputs, risk treatment decisions, and remediation tracking, so you can answer audits without stitching together spreadsheets and tickets.

Required evidence and artifacts to retain

Keep these artifacts in an audit-ready folder with version history:

• Risk analysis methodology document (scope, rating model, update triggers).
• ePHI system inventory and data flow diagrams.
• Risk register with inherent/residual risk and control mapping.
• Risk treatment decisions (including formal risk acceptances with approver).
• Remediation plan/backlog with owners, dates, and completion evidence.
• Validation records for closed items (test results, screenshots, configurations).
• Management review evidence (minutes, approvals, steering committee notes).

Common exam/audit questions and hangups

Auditors and customers commonly probe:

• “Show me where ePHI lives and how it moves.” Hangup: no inventory or incomplete cloud/third party coverage.
• “How do you know this risk analysis is current?” Hangup: no update triggers; last update predates major changes.
• “Which high risks are open, and why?” Hangup: remediation plan exists but no status, no owners, or no validation.
• “What risks did you accept?” Hangup: informal acceptance with no approver or rationale.
• “How do you address availability?” Hangup: risk analysis focuses on breaches but ignores ransomware resilience and restore capability.

Frequent implementation mistakes (and how to avoid them)

1. Calling a vulnerability scan a risk analysis. Fix: tie findings to ePHI assets, likelihood/impact, and treatment decisions.
2. Ignoring third party ePHI paths. Fix: include third parties in data flows and risks; link to contracts and access methods.
3. No residual risk concept. Fix: document existing controls and the remaining risk after controls.
4. Remediation without verification. Fix: define closure evidence and require it before closing risks.
5. Stale artifacts. Fix: set update triggers tied to change management and major third party events.

Enforcement context and risk implications

No specific public enforcement cases were provided in the source catalog for this page, so this guidance stays grounded in the HIPAA Security Rule requirement text ¹. Practically, weak risk analysis documentation increases exposure during investigations because you cannot demonstrate that your safeguards were selected based on a systematic assessment of ePHI risks.

Practical 30/60/90-day execution plan

Days 1–30: Get to a defensible baseline

• Assign an accountable owner (Security/GRC) and executive sponsor (CCO/CIO).
• Write the risk analysis methodology (scope, scoring, triggers).
• Build the first-cut ePHI inventory and list of third parties that touch ePHI.
• Run targeted workshops on top ePHI workflows and draft initial risk register.

Deliverables: methodology, inventory v1, risk register v1.

Days 31–60: Turn findings into risk management

• Prioritize top risks and open remediation items with owners and dates.
• Document risk acceptances with approvals and rationale.
• Establish validation steps for each remediation type.
• Stand up a recurring review cadence with IT/Security/Compliance.

Deliverables: remediation backlog, acceptance log, validation templates, governance cadence.

Days 61–90: Prove operation and make it repeatable

• Validate and close early remediation items with evidence.
• Expand scope to remaining ePHI systems and non-obvious repositories (logs, support tools, backups).
• Integrate triggers into change management and third party onboarding.
• Prepare an “audit pack” export: inventory → risks → treatments → evidence.

Deliverables: audit pack, inventory v2, risk register v2, closed-item evidence set.

Frequently Asked Questions

How detailed does the HIPAA risk analysis need to be?

Detailed enough that a reviewer can trace each major ePHI system and workflow to specific risks, existing controls, and remediation decisions ¹. If you cannot explain how your ratings were determined, the analysis is usually too thin.

Can we do this as a qualitative assessment, or do we need numbers?

HIPAA requires a documented risk analysis, not a specific scoring formula ¹. A consistent qualitative model is acceptable if you document the criteria and apply it uniformly.

How often should we update the risk analysis?

Update it on a defined cadence and whenever major changes occur, then document the trigger and what changed. The key is demonstrating you “maintain” it as your environment evolves ¹.

Do third parties have to be included in our risk analysis?

If a third party creates, receives, maintains, or transmits ePHI for you, that relationship affects your ePHI risks and should be reflected in scope, data flows, and risk entries ¹.

What’s the minimum evidence to prove risk management (not just risk analysis)?

Keep a remediation tracker that ties each prioritized risk to an owner, status, and closure evidence, plus formal records for any accepted risks. Auditors look for proof that identified risks lead to action ¹.

We have multiple business units. Do we need separate risk analyses?

You need coverage across all ePHI locations and workflows within the scope of your Covered Entity or Business Associate operations ¹. Many organizations keep one methodology and consolidate results, then segment the inventory and risk register by unit or system owner.

Related compliance topics

• 2025 SEC Marketing Rule Examination Focus Areas
• Access and identity controls
• Access Control (AC)
• Access control and identity discipline
• Access control lifecycle management

Footnotes

1. HIPAA Security Rule (45 CFR Part 164 Subpart C)